FDA Inspection 1120306 — ONCORE - SAN MARCOS
The FDA completed an inspection of ONCORE - SAN MARCOS on March 6, 2020 in San Marcos, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 6, 2020
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- San Marcos, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |